Analytical validation of the new plasma calibrated Accu-Chek Test Strips (Roche Diagnostics).

Venous and capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay, glucose dehydrogenase (mutant GDH-PQQ) E. Applicant: Roche Diagnostics Corporation F. Proprietary and Established Names: ACCU-CHEK Performa Blood Glucose Monitoring System

"No coding" of glucose test strips: a roche perspective.

INTRODUCTION Glucose test strips vary slightly from batch to batch. These variations are accounted for by a batch-specific "code": a set of parameters defining the relationship between the signal change induced on the glucose test strip and the blood glucose concentration. METHODS We assessed the impact on accuracy of miscoding the ACCU-CHEK Aviva system across a wide range of glucose test st...

Assessment of three frequently used blood glucose monitoring devices in clinical routine.

BACKGROUND Self-monitoring of blood glucose plays an important role in the management of diabetes and has been shown to improve metabolic control. The use of blood glucose meters in clinical practice requires sufficient reliability to allow adequate treatment. Direct comparison of different blood glucose meters in clinical practice, independent of the manufactures is scarce. We, therefore, aime...

Self-monitoring of blood glucose levels requires intensive training for use of meters to obtain reliable and clinically relevant measurements.

BACKGROUND Anecdotal reports from pediatric sites have indicated that some blood glucose meters may display wrong and misleading numbers rather than error indications, when operated in deviation from the instructions for use (IFU), eg by manipulating the strip during the count-down phase. METHODS This study was performed with 60 patients with diabetes (32 female, 28 male, 21 type 1, 39 type 2...

Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices.

BACKGROUND It has been demonstrated that dynamic electrochemistry can be used to correct blood glucose measurement results for potentially interfering conditions, such as humidity, hematocrit (HCT) variations, and ascorbic acid. The purpose of this laboratory investigation was to assess the potential influence of hematocrit variations on a variety of blood glucose meters applying different meas...